JP6763870B2 - Stent grafts on the renal arteries and the thoracic aortic arch and how to use them - Google Patents

Description

Cross-references to related applications This application is of US Patent Provisional Application Nos. 62 / 138,299 and July 27, 2015, filed March 25, 2015, each of which is incorporated herein by reference in its entirety. It claims the priority of US Patent Provisional Application No. 62 / 197,304.

Background Unless otherwise noted herein, the materials described in this section are not prior art in the claims of the present application and are not recognized as prior art by inclusion in this section. ..

Suprarenal and pararenal artery aneurysms have a very short neck (ie, less than 5 mm) or have a few visceral arteries (eg, right and left renal arteries, and optionally the superior mesenteric artery). A subrenal artery aneurysm located within about 5 mm of the renal artery, including an artery (“SMA”), extending within about 5 mm of the SMA. Since a suprarenal artery aneurysm typically contains only part of the major viscera of the aorta, it is the renal artery, SMA, that provides blood flow to obtain a proximal seal between the stent graft body and the vascular tissue. And because it must be maintained in the celiac artery, it is difficult. One technique for treating a suprarenal artery aneurysm may include placing a bridging stent graft in each of the aforementioned arteries, for example via a branched or manifold stent graft. Although this technique can provide sufficient adjacency sealing between the stent graft and the vascular structure, adjacency sealing can also create new risks, ie, blood flow to the lumbar artery blocks the adjacency sealing. Can be done. Specifically, the lumbar arteries tend to perfuse the spinal cord with blood, and they tend to concentrate in the area of the thoracic aorta above the celiac artery in the "sealing zone" with stent grafts placed and anchored within the aorta. Therefore, by blocking blood flow to the lumbar arteries, the patient can become hemodynamically unstable (ie, the blood pressure becomes excessively low and the tissue cannot be adequately perfused with blood) and is paraplegic to the patient. May pose a risk of paraplegia. In addition, large vessels located within the aortic arch near the heart can also have blood flow blockages by known treatment devices and methods for thoracic aneurysms, which can lead to stroke.

Overview The exemplary embodiments beneficially provide, for example, stent grafts for treating supracericular, supraclavicular, ascending, transverse and descending thoracic aneurysms, as well as methods of placing these stent grafts. The stent grafts disclosed herein offer multiple advantages beyond known art. For example, a stent graft can repair a suprarenal artery aneurysm intravascularly while minimizing the coverage of the aorta above the celiac artery. This can be achieved through a recess or scallop-shaped hole defined at the proximal end of the stent graft body and placed under the lumbar artery when placed in vivo, with the rest of the proximal end of the stent graft being the aorta. Extends along the main part of the internal organs. The proximal end of the stent-graft body, on the other hand, has a two-tiered structure that defines the upper part, which is arranged along the most proximal edge of the stent-graft body, and the lower part, which is arranged along a recess or scallop-shaped hole. Can be supported by a proximal sealing ring.

In addition, the stent graft may beneficially provide a diaphragm disposed inside the main lumen that defines at least three openings. In one embodiment, these openings may include first, second, third and fourth openings. This sequence may allow one or more bridging stents that can be linked directly to these openings or to a stent graft that is linked to these openings. This allows, for example, the aneurysm distal to the stent graft body to be removed downward from the celiac artery.

Further, in one embodiment, for stent placement in the renal arteries, the extension of the stent graft can be connected to the third and fourth openings of the septum and intersect each other in a gently descending passage. Can be arranged as follows. This configuration can advantageously allow non-obstruction of blood flow and minimize both the possibility of kinking of the stent graft and the possibility of blood flow turbulence. Similarly in a further embodiment, the third and fourth openings may be located opposite the diaphragm between the side wall of the stent graft body and the center of the lumen defined by the stent graft body. This arrangement is gentle because the free ends of the stent graft extension connected to the third and fourth openings can have more space to intersect to the opposite side of the stent graft body. Can provide a passage that descends into. In an alternative embodiment, the third and fourth openings may be located in the diaphragm closer to the center of the lumen defined by the stent graft body. This sequence can beneficially result in higher blood flow velocities.

In addition, in one embodiment, a permeable membrane may be provided that covers at least one of a visceral-vascular opening and two kidney openings. This permeable membrane can advantageously increase the area of contact with the aortic wall upon placement, but at the same time temporarily allow blood flow to pass through the membrane if, for example, heparinization inhibits clot formation. enable. The permeable membrane can be perforated by a guide wire and / or a stent graft, and any resistance to the stent graft can be ignored. When placed in vivo, thrombi can form on the permeable membrane, which beneficially expands the sealing zone of the stent graft on the aortic wall.

Also in one embodiment, a visceral chamber is defined in one of the diaphragm and the second opening, and in the side wall of the stent graft body and one of the visceral-vascular openings defined in the side wall of the stent graft body. It can be defined by a visceral sidewall connected to. This visceral cavity can beneficially continue natural blood flow to the abdominal cavity and SMA arteries. In addition, in events where the aneurysm progresses proximally after placement of the stent graft, the aneurysm can be repaired by a standard thoracic stent graft that can be placed and can fit directly into the lumen of the stent graft body.

For thoracic aneurysms, the stent graft can provide blood flow to all three large vessels, thereby treating from the sinus ascending aortic junction during debranching of the aneurysm and providing non-obstruction of blood flow. .. The stent graft may also advantageously provide the surgeon with the flexibility to choose whether to place the arch bypass graft first or debranch the macrovascular. For example, it may be desirable to first debranch the macrovascular vessel, thereby providing stroke protection during the installation of the next larger arch bypass graft. Therefore, the stent graft can be selected by the surgeon according to the risk based on the symptoms of each patient.

Thus, in one embodiment, (a) a stent graft body defining a lumen having a first end and a second end, and (b) a diaphragm connected to the stent graft body and defining at least three openings. (C) At least three stent graft extensions, each defining a lumen, with the first end of each of the at least three stent graft extensions connected to one of the at least three openings. Provided are stent grafts that include at least three stent graft extensions and features.

In a second aspect, the stent graft is (d) a visceral-vascular opening defined on the side wall of the stent graft body between the first end and the second end of the stent graft body. The diaphragm is disposed within the lumen of the stent graft body, and at least three openings in the diaphragm include a first opening, a second opening, a third opening and a fourth opening. It is defined by a visceral-vascular opening and (e) a side wall connected to one of the second opening and the diaphragm and one of the visceral-vessel opening and the side wall of the stent graft body. Includes features of visceral cavities.

In a third aspect, the stent graft is (a) a visceral-vascular opening defined on the side wall of the stent graft body between the first end and the second end of the stent graft body. The diaphragm is disposed within the lumen of the stent graft body, and the internal organs include at least three openings of the diaphragm including a first opening, a second opening, a third opening and a fourth opening. -Includes features of blood vessel openings.

In a fourth aspect, a delivery catheter comprising (a) introducing a guide wire into an arterial configuration of any suitable size via arterial access and (b) a stent graft according to the first aspect onto the guide wire. And (c) moving the delivery catheter along the guide wire to introduce the delivery catheter into the appropriately sized arterial configuration via arterial access, and (d). A method of placement of the stent graft is provided, comprising the step of placing the stent graft into an arterial structure of the appropriate size and / or a lumen of a previously placed stent graft.

In a fifth aspect, the stent graft comprises (a) a stent graft body defining a lumen having a first end and a second end, and (b) a first opening, a first opening, which is connected to the stent graft body. A first stent graft extension having a diaphragm defining a second opening and a third opening, and (c) a first end and a second end, said first stent graft extension. A first stent graft in which the presence has a single lumen and the first end of the extension of the first stent graft is connected to the diaphragm and is arranged surrounding the first opening. An extension and (d) a second stent graft extension having a first end and a second end, wherein the second stent graft extension is simply at the first end. It has one lumen and has a bifurcation that defines the two lumens at the second end, the first end of the second stent graft extension being connected to the diaphragm and the second A second stent-graft extension, and (e) a third stent-graft extension having a first end and a second end, arranged around the opening of the third. The stent graft extension has a single lumen at the first end and the first end of the third stent graft extension is connected to the diaphragm and surrounds the third opening. Includes features of an arranged third stent graft extension.

In a sixth aspect, the stent graft comprises (a) a stent graft body defining a lumen having a first end and a second end, and (b) being connected to the stent graft body within the lumen, at least three. The diaphragm defining the openings and (c) at least three stent graft extensions, each defining a lumen, with the first end of each of the at least three stent graft extensions being the at least three openings. At least three stent graft extensions connected to one of the portions, (d) a visceral-vascular opening defined on the side wall of the stent graft body, and (e) said distal to the septum. It comprises the features of two kidney openings defined on the side wall of the stent graft body and (f) a permeable membrane material covering at least one of the visceral-vascular opening and the two kidney openings. ..

These and other aspects, advantages, and alternatives will become apparent to those skilled in the art by reading the detailed description below, with reference to the accompanying drawings as appropriate.

It is a front view of the stent graft by an exemplary embodiment. FIG. 1 is a side sectional view of Category A: A in FIG. It is a back view of the stent graft according to the exemplary embodiment of FIG. It is a side view of the stent graft according to the exemplary embodiment of FIG. FIG. 4 is a top sectional view of Category B: B in FIG. It is a top view of the stent graft according to the exemplary embodiment of FIG. It is a front view of the stent graft by the second exemplary embodiment. FIG. 5 is a front view of a stent graft according to a second exemplary embodiment having a fifth opening connected to a stent expansion graft. It is a side view of the stent graft according to the exemplary embodiment of FIG. 7A. FIG. 7B is a side view of a stent graft according to an exemplary embodiment of FIG. 7B. It is a top view of the stent graft according to the third exemplary embodiment. 9 is a side sectional view of a stent graft according to an exemplary embodiment of FIG. It is a top view of the stent graft according to the 4th exemplary embodiment. It is a front view of the stent graft according to the exemplary embodiment of FIG. It is a side view of the stent graft by the exemplary embodiment of FIG. FIG. 5 is a side view of the stent graft according to the exemplary embodiment of FIG. 11, further comprising an inverted U-shaped visceral-vascular opening defined on the side wall of the stent graft body. It is a top view of the stent graft according to the fifth exemplary embodiment. It is a front view of the stent graft by the exemplary embodiment of FIG. It is a top view of the stent graft according to the sixth exemplary embodiment. FIG. 5 is a front sectional view of the abdominal aorta, including a perspective view of a stent graft according to an exemplary embodiment of FIG. 1 in an expanded state. FIG. 5 is a front sectional view of the abdominal aorta, including a perspective view of a stent graft according to an exemplary embodiment of FIG. 11 in an expanded state. FIG. 3 is a front sectional view of the aortic arch, including a perspective view of a stent graft according to an exemplary embodiment of FIG. 11 in an expanded state. FIG. 6 is a front sectional view of the abdominal aorta, including a perspective view of a stent graft according to an exemplary embodiment of FIG. 14 in an expanded state. FIG. 5 is a front sectional view of the abdominal aorta, including a perspective view of a stent graft according to an exemplary embodiment of FIG. 7 in an expanded state. FIG. 6 is a front sectional view of the abdominal aorta, including a perspective view of a stent graft according to an exemplary embodiment of FIG. 16 in an expanded state. FIG. 3 is a front sectional view of the abdominal aorta, including a perspective view of a stent graft according to an exemplary embodiment of FIG. 13B in an expanded state. It is a side view of the stent graft by the 7th exemplary embodiment. It is a perspective view of the stent graft according to the eighth embodiment. FIG. 5 is a top view of a stent graft according to an exemplary embodiment of FIG. 25A. It is a perspective view of the stent graft according to the ninth embodiment. It is a top view of the stent graft according to the exemplary embodiment of FIG. 26A. It is a perspective view of the stent graft according to the sixth embodiment. It is a top view of the stent graft according to the exemplary embodiment of FIG. 27A.

Detailed Description An exemplary stent graft and a method of arranging the stent graft are described herein. Any exemplary embodiment or feature described herein is not necessarily considered to be preferred or advantageous over other embodiments or features. The exemplary embodiments described herein are not meant to be limiting. It will be immediately appreciated that certain aspects of the disclosed methods can be arranged and combined in a variety of different configurations, all of which are contemplated herein.

Moreover, the individual sequences shown in the figure should not be considered limiting. It must be understood that other embodiments may include some of the elements shown in a given figure. In addition, some of the illustrated elements can be combined or omitted. Further exemplary embodiments may include elements not shown in the figure.

As used herein, "about" means ± 5%.

The diameter range used herein relates to the unsuppressed exvivo state of the stent graft and the extension of the stent graft. If the stent graft and the extension of the stent graft are indwelled in vivo, the diameter range will be about 10-20% smaller than in the ex vivo state.

As used herein, "on the renal artery" means the region adjacent to the kidney.

As used herein, "sub-kidney" means a situation or development under the kidney.

As used herein, "major visceral part" refers to the portion of the aorta attached to the renal artery, superior mesenteric artery ("SMA"), and celiac artery.

As used herein, the "base end" refers to the end of the stent graft body that is closer to the patient's heart than the "tip" during placement.

As used herein, a "sealing ring" is a structure configured to apply an outward circumferential force to create a seal with a liquid. In some embodiments, this circumferential force can be applied laterally to the side wall of the stent graft body. In other embodiments, a circumferential force can be applied to keep the hole or opening in the side wall of the stent graft body both open and in contact with the vascular structure. The sealing ring can be circular or elliptical, continuous or discontinuous, and / or outline such that it accommodates a recess or scallop-shaped hole in the side wall of the stent graft body, among other possibilities. Or can have a two-tiered shape. Sealing rings are injectable, which can form elastic recoil materials such as nitinol, standard stent structures, or straight reinforced wires, gaskets or sealing structures similar to "O" rings, among other possibilities. Sealant may be included.

As used herein, "passive fixation" refers to friction, interactions between fabrics of the graft, radial forces of the stent structure, and blood pressure that holds the components of the stent graft together at overlapping sites.

As used herein, "active fixation" includes hooks, bidirectional hooks, stent structural elements, anchors, staples, bioactive adhesives, or combinations thereof, among other possibilities. Refers to the feature of binding to a stent, graft or stent graft, or other stent graft, which can actively engage the vascular structure.

As used herein, "thread" refers to a low friction material such as GORE-TEX® suture.

As used herein in the context of measurement, "about" means ± 5%.

As used herein, a "stent graft" is a tubular, radially dilated device that contains a liquid-tight (ie, blood-sealed) fabric supported by a stent and can be used to bridge an affected artery. Such stent grafts, as well as methods of their placement and use, are known to those of skill in the art. For example, a vascular sheath can be introduced into the artery of a patient through which articles such as guide wires, catheters, and finally stent grafts are passed, without limitation.

As used herein, "stent" is typically a cylindrical frame, which means any device or structure that adds stiffness, dilation, or support to an artificial organ or natural vascular structure, but is a "stent graft." "Refer to an artificial organ containing a bonded stent and graft material that forms a liquid-tight lumen through at least a portion of its length. As used herein, "liquid tight" is configured to prevent the passage of blood or blood products (ie, serum and its contents), thereby preventing endoleak, or in vivo placement. Means a barrier that can be prevented by. For example, the stent structure can include coiled, mesh, zigzag or woven wire or laser cut tubes. A "graft" is a substantially cylindrical linear or non-linear graft in a tapered configuration that can be placed inside, outside, or both of the stent. In some embodiments, the graft can be woven as a unit structure with multiple lumens. For example, the stent graft body, septum, two renal lumens, subrenal lumens and visceral cavities can all be woven together as a unit structure or otherwise assembled together to form a unit structure. In addition, the stent structure, when used in concert with the graft, may further include a series of distant stent rings disposed along the graft. A wide variety of attachment mechanisms, including, but not limited to, sutures, adhesive bonds, heat welds, and ultrasonic welds, are available to bond stents and grafts together.

Stents are, but are not limited to, biocompatible metals that attach to grafts, implantable quality stainless steel wires. It can be made of any suitable material, including nickel and titanium alloys, as well as biocompatible plastics. Any suitable liquid-tight (ie, blood-sealing) graft material can be used. In a preferred embodiment, the graft material is, but is not limited to, woven or woven polyesters such as poly (ethylene terephthalate), polylactides, polyglycolides, and copolymers thereof; fluorinated polymers such as PTFE, extended. Mold or electrospan PTFE and poly (vinylidene fluoride); polysiloxanes such as polydimethylsiloxane; and polyether urethanes, polyurethane ureas, polyether urethane ureas, polyurethanes containing carbonic acid bonds, woven nickel-titanium, and It is a biocompatible fabric including polyurethane containing a siloxane segment. Materials that are not biocompatible by nature can undergo surface modifications to make the material biocompatible. Examples of surface modifications include graft polymerization of biocompatible polymers from the surface of materials, surface coating with crosslinked biocompatible polymers, chemical modifications with biocompatible functional groups, and heparin or other substances. The immobilization of the compatibilizer can be mentioned. The graft material may also include extracellular matrix material.

The coated stent graft can be made of any suitable material, including, but not limited to, a nickel-titanium alloy stent with a polytetrafluoroethylene (ePTFE) lining. The stent graft is preferably coated and flexible. The stent graft may include any other suitable component, such as, but not limited to, surface modification, including covalent attachment of heparin.

In the first aspect shown in FIGS. 9 to 16, the present invention
A stent graft body that defines a lumen with a first end and a second end,
A diaphragm that is connected to the stent graft body and defines at least three openings.
At least three stent graft extensions, each defining a lumen, with the first end of each of the at least three stent graft extensions connected to one of the at least three openings. Three stent graft extension parts and
Provided are stent grafts, including.

Here, with reference to FIGS. 9-16, a stent graft 200 comprising a lumen graft body 205 defining a lumen having a first end 207 and a second end 209 is shown. In one embodiment, the first end 207 of the stent graft body 205 is configured to be closer to the patient's heart than the second end 209 or tip of the stent graft body 205 upon placement. It can be the base of 200. The diaphragm 210 may be connected to the stent graft body 205 at some location within the lumen, or at the first end 207 or the second end 209. In one embodiment, the diaphragm 210 may be connected to the stent graft body 205 at a position ranging from the second end or tip 209 of the stent graft body 205 to the central section of the stent graft body 205. This arrangement can beneficially exert pressure from the bloodstream on the proximal side wall of the stent graft body over the septum, helping to seal and secure the stent graft to the indwelling lumen.

The diaphragm 210 defines at least three openings. For example, in one embodiment, the diaphragm 210 has a first opening 230 connected to a first stent graft extension 231 and a second opening 235 connected to a second stent graft extension 236. A third opening 220 connected to the third stent graft extension 221 and a fourth opening 225 connected to the fourth stent graft extension 226 can be defined. In various embodiments, the first opening 230 can be used to receive a bridging stent in an arrangement in the subrenal segment of the aorta or other natural vessel, and the second opening 235 is the peritoneal and SMA. Or it can be used to receive a bridging stent in an arrangement in another natural vessel, the third and fourth openings 220, 225 to receive a bridging stent in an arrangement in the renal artery or other natural vessel. Can be used for. Alternatively, the first opening 230 can be used to receive a bridging stent in an arrangement in the aortic arch, and the second opening 235 is an anonymous vessel (right common carotid artery and right subclavian artery) or other natural. Can be used to receive bridging stents in vascular arrangements, third and fourth openings 220, 225, bridging stents in arrangements in the left common carotid and left subclavian arteries or other natural vessels. Can be used to receive.

In one embodiment shown in FIG. 11, the first opening 230 may have a diameter larger than the diameter of the second opening 235. In another embodiment shown in FIG. 11, the diameter of the second opening 235 can be larger than the diameter of the third opening 220 and the diameter of the fourth opening 225. In the alternative embodiments shown in FIGS. 9 and 14, the second opening 235, the third opening 220 and the fourth opening 225 may each have the same diameter. In yet another embodiment shown in FIG. 11, the first opening 230 and the second opening 235 may be defined on opposite sides within the diaphragm 210. In a further embodiment, the first opening 230, the second opening 235, the third opening 220 and the fourth opening 225 are different quadrants 211 of the diaphragm 210, respectively, as shown in FIG. Can be defined within ~ 214.

In the further embodiments shown in FIGS. 9, 14 and 16, the fifth opening 237 may also be defined at the diaphragm 210 and connected to the fifth stent graft extension 238. In one embodiment, the fifth opening 237 can be used to receive a bridging stent in an arrangement in the abdominal cavity and SMA or other natural blood vessels. In one embodiment, the first opening 230 may have a diameter larger than the diameter of the second opening 235 and the diameter of the fifth opening 237 (see FIGS. 9, 14 and 16). In a further embodiment shown in FIG. 16, the diameter of the second opening 235 and the diameter of the fifth opening 237 are larger than the diameter of the third opening 220 and the diameter of the fourth opening 225. Can be. In an alternative embodiment as shown in FIGS. 9 and 14, the diameter of the second opening 235 and the diameter of the fifth opening 237 are the diameter of the third opening 220 and the diameter of the fourth opening 225. Can have the same dimensions as the diameter of. In one embodiment, as shown in FIG. 16, the first opening 230, the second opening 235 and the fifth opening 237 can be arranged linearly within the diaphragm 210 and the third opening. The portions 220 and the fourth opening 225 may be arranged on opposite sides of the first, second and fifth openings 230, 235 and 237. In addition, as shown in FIG. 9, the third opening 220 and the fourth opening 225 can be arranged adjacent to each other and together on the opposite side of the first opening 230 in the diaphragm 210. Can be arranged in. In a further embodiment, as shown in FIG. 14, the first opening 230 may be arranged within the first quadrant 211 of the diaphragm 210 and the third opening 220 may be the second of the diaphragm. The second opening 235 and the fifth opening 237 can be arranged within the third quadrant 213 of the septum, and the fourth opening 225 can be arranged within the diaphragm 210. Can be arranged within the fourth quadrant 214 of.

In yet another embodiment, at least a portion of the diaphragm 210 may be angled with respect to the side wall 218 of the stent graft body 205 towards the second end 209 of the stent graft body 205. As shown in FIGS. 9-10, in one embodiment, the openings 220, 225, 230 of the diaphragm 210 may be defined at the center of the diaphragm 210, which may be substantially in the shape of a funnel. .. In a further embodiment, at least one end of the stent graft extension can be tapered adjacent to the septum 210, as illustrated and described with respect to the first aspect of the invention. This sequence may assist in the alignment of the guide wire and the entry of the stent graft extension into each lumen for placement of the extension or bridging stent, and may promote laminar blood flow.

In addition, in one embodiment, the opening of the diaphragm 210 may enhance the fit with, for example, a bridging stent or a stent graft at the extension. Reinforcing materials include nitinol, for example any non-expandable, foldable material that is biocompatible. In a further embodiment, the diaphragm 210 may have an expandable frame that can be configured to apply an outward radial force to the stent graft body 205, as described with respect to the first aspect of the invention. This frame may assist in fixation and sealing with the vascular lumen.

In one embodiment, the diameter of the stent graft body 205 can be in the range of about 20 mm to about 65 mm, preferably about 23 mm to about 40 mm or about 28 mm to about 36 mm for the visceral division, preferably about 30 mm to about 30 mm for the thoracic aorta. It can be in the range of 65 mm or about 40 mm to about 55 mm. In addition, the length of the stent graft body 205 can be in the range of about 10 mm to about 150 mm, preferably about 20 mm to about 60 mm. Further, each of the second stent graft extension 236 and the fifth stent graft extension 238 may have a length in the range of about 0.5 mm to about 40 mm in one example. In yet another embodiment, the diameter of the second stent graft extension 236 and the diameter of the fifth stent graft extension 238 can each be in the range of about 6 mm to about 14 mm.

In one embodiment, the first stent graft extension 231 can have a length of at least 30 mm and a diameter in the range of about 8 mm to about 25 mm. In another embodiment, the first opening 230 may have a diameter in the range of about 8 mm to about 25 mm. In a further embodiment, the third opening 220 and the fourth opening 225 can each have a diameter in the range of about 4 mm to about 25 mm. In another embodiment, the third stent graft extension 221 and the fourth stent graft extension 226 may each have a diameter in the range of about 4 mm to about 12 mm.

The stent graft 200 may also include a plurality of sealing rings attached to the stent graft body 205, as previously described with respect to the first aspect of the invention. For example, in one embodiment, the plurality of sealing rings may include a proximal sealing ring 245 attached to the stent graft body 205 or directly adjacent to the first end 207. In one embodiment, the proximal sealing ring 245 may have a two-tiered structure that defines the top and bottom. In an alternative embodiment, the proximal sealing ring can be ring-shaped.

In one embodiment shown in FIGS. 13B and 23, the stent graft has an inverted U shape defined on the side wall of the stent graft body 205 and extends from the diaphragm 210 to the second end 209 of the stent graft body 205. It may include a visceral-vascular opening 275. Visceral openings can advantageously avoid blocking blood flow and allow access to the abdominal cavity and SMA arteries. In a further embodiment, the plurality of sealing rings may include a distal sealing ring 176 connected to the stent graft body 205 between the diaphragm 210 and the second end 209 of the stent graft body 205. The distal sealing ring 276 may have a radial portion 277 arranged around a portion of the circumference of the stent graft body 205 and an arch portion 278 aligned with the visceral-vascular opening 275. In one embodiment, each end of the radial portion 277 of the distal sealing ring 276 transitions to the bow 278 via two curve compartments 279, each having a curve radius in the range of about 20 mm to about 50 mm. Can be. In yet another embodiment, the length of the stent graft body 205 between the first end 207 and the diaphragm 210 can be in the range of about 10 mm to about 150 mm. In a further embodiment, the length of the stent graft body 205 from the diaphragm 210 to the second end 209 of the stent graft body 205 can be in the range of about 0.05 mm to about 40 mm.

In another embodiment, as described below with respect to a second aspect of the invention, the pair of opposing helical stent structures comprises a first stent graft extension 231 and a second stent graft extension 236, a third stent graft. It may be connected to one or more of the extension 221 and the fourth stent graft extension 226 and the fifth stent graft extension 238.

In yet another embodiment, the first end 207 of the stent graft body 205 can be coupled to a fixed stent as described below with respect to the second aspect of the invention.

In an alternative embodiment shown in FIG. 19, the stent graft may include a stent valve 280 attached to the first end 207 of the stent graft body 205. In this arrangement, the free end of the stent valve can be coated and a portion of the stent valve extending between the free end and the stent graft body 205 can be uncoated. As used herein, a "stent valve" is a percutaneous self-expanding valve attached to the proximal or first end 207 of a stent graft body 205 by an uncoated portion that overlaps the coronary arteries to maintain blood flow. is there. An exemplary embodiment of a stent valve includes Corevalve® manufactured by Medtronic. In one embodiment, the free end of the stent valve may be coated with an impermeable natural or synthetic material. In one embodiment, the stent valve can be placed in the outflow tube of the aortic valve. The stent valve anchoring mechanism is obtained, for example, from a funnel shape having a larger diameter at the free end and a smaller diameter at the point where the coated portion meets the uncoated portion.

In the second aspect, the stent graft is
A stent graft body that defines a lumen with a first end and a second end,
A diaphragm that is connected to the stent graft body and defines at least three openings.
At least three stent graft extensions, each defining a lumen, with the first end of each of the at least three stent graft extensions connected to one of the at least three openings. Three stent graft extension parts and
A visceral-vascular opening defined on the side wall of the stent graft body between the first end and the second end of the stent graft body, wherein the diaphragm is disposed within the lumen of the stent graft body. And a visceral-vascular opening, wherein at least three openings in the diaphragm include a first opening, a second opening, a third opening and a fourth opening.
A visceral cavity defined by a side wall connected to a second opening and one of the diaphragms, and to one of the visceral-vascular opening and the side wall of the stent graft body.
I will provide a.

Here, referring to FIGS. 1 to 6, it has an inlet 106 defined by the first end or proximal end 107 of the stent graft body 105 and is defined by the second end or tip 109 of the stent graft body 105. A stent graft 100 comprising a lumen-defining stent graft body 105 having an outlet 108 is shown. In one embodiment, a portion of the lumen of the stent graft body 105 arranged between the diaphragm 110 and the proximal end 107 of the stent graft body 105 has a diameter in the range of about 20 mm to about 65 mm, preferably about 20 mm to about 46 mm. Can have. In another embodiment, the stent graft body 105 has a length in the range of about 10 mm to about 150 mm and has a first end 107 of the stent graft body 105 and a first end of the visceral-vascular opening 115. It may extend between parts 116. In a further embodiment, the stent graft body 105 has a length in the range of 0 mm to about 40 mm with a second end or tip 117 of the visceral-vascular opening 115 and a second end of the stent graft body 105. It may extend between parts 109.

The stent graft 100 includes a diaphragm 110 disposed within the lumen of the stent graft body 105 and connected to the stent graft body 105. The diaphragm 110 defines a first opening 130, a second opening 135, a third opening 120 and a fourth opening 125. In one embodiment, the first opening 130 can be used to stent the subrenal segment, the second opening 135 can be used to stent the abdominal cavity and SMA arteries, and a third. The opening 120 and the fourth opening 125 of the canal can be used to stent the renal artery. The second opening 135 can be aligned within the quadrant of the diaphragm 110 lying on the visceral-vascular opening 115 described in more detail below, the first opening 130 and the third and fourth openings. The portions 120, 125 may be arranged in various configurations within the same or other quadrants of the diaphragm 110. For example, in one embodiment, as shown in FIG. 6, the first opening 130 and the second opening 135 may be arranged on opposite sides within the diaphragm 110, with the third opening 120 and the fourth opening 120. The openings 125 may also be similarly arranged on opposite sides within the diaphragm 110 between the first opening 130 and the second opening 135. Alternatively, the third and fourth openings 120, 125 may be arranged on the same side within the diaphragm 110 between the first opening 130 and the second opening 135. In another embodiment, one of the first opening 130, and the third and fourth openings 120, 125, faces the diaphragm 110 on which the other opening can be arranged between them. Can be arranged in. In a further embodiment, the first opening 130, as well as the third and fourth openings 120, 125 may be arranged so that no other inlet is present on the directly opposite side of the second opening 135.

In one embodiment, the diaphragm 110 can be tilted or tapered within the area surrounding these various openings. In one embodiment, the second opening 135 is, among other possibilities, as a V-shaped semicircular opening with a radius in the range of about 5 mm to about 15 mm, or in the range of about 6 mm to about 20 mm. It can be defined as a full circular opening with an inner diameter. In a further embodiment, the third opening 120, the fourth opening 125, and the first opening 130 may have a substantially circular shape. In one embodiment, the three stent graft extensions 121, 126 and 131 are liquid-tight (blood-sealed) prior to placement of the stent graft 100, with a third opening 120, a fourth opening 125 and a first, respectively. It can be directly connected to one opening 130. Each of these stent graft extension 121, 126, 131 is configured to define a lumen and receive an extended or bridging stent graft that can be held in place via passive or active fixation. This sequence may provide blood flow between the stent graft 100 and the renal arteries and / or to the subrenal arteries, including, for example, the aorta and common iliac arteries.

In various embodiments, the stent graft extension 121, 126, 131 can be straight or gradually spread, and the distal free ends 123, 128, 133 are free to place the bridging stent graft. Can be mobile. In one embodiment, the stent graft extension 131 coupled to the first opening 130 may have a length of at least 30 mm and, in another embodiment, a length in the range of about 10 mm to 120 mm. Can be done. And in another embodiment, the stent graft extension 131 may have a diameter in the range of about 8 mm to about 25 mm. In another embodiment, the first opening 130 may have a diameter in the range of about 8 mm to about 25 mm. In yet another embodiment, the diameter of the first opening 130 is the diameter of the connected stent graft extension 131 so that the first end or proximal end of the stent graft extension 131 is tapered 132. Can be larger than. In another embodiment, the third and fourth openings 120, 125 may each have a diameter in the range of about 4 mm to about 25 mm. In one embodiment, the stent graft extension 121, 126 connected to the third and fourth openings can each have a diameter in the range of about 4 mm to about 18 mm. In yet another embodiment, the diameters of the third and fourth openings 120, 125 are such that the first end or proximal end of each of the stent graft extension 121, 126 is tapered 122, 127. , Can be larger than the respective diameters of the stent graft extension 121, 126. Tapering from the septal opening to the various stent graft extensions can assist in aligning the guide wires for placing dilating or bridging stents and entering each lumen, facilitating laminar blood flow. obtain. In another embodiment, the stent graft extension 121, 126 and 131 may be placed separately after placement. In this embodiment, the stent graft extension 121, 126, 131 may have a flared proximal end that is arranged proximal to the septum by placement.

In one embodiment, a pair of opposing helical stent structures may be connected to one or more of the stent graft extension 121, 126 and 131 and extend along their length. The helical stent structure can advantageously prevent lumen elongation. These helical stent structures can be made from biocompatible materials with elastic shape memory such as nitinol, stainless steel, plastics, polymers or any combination of materials thereof, among other possibilities.

In a further embodiment, according to the first, second and third aspects of the present disclosure, the diaphragm 110 may have an expandable frame 111. The expandable frame 111 may be configured to apply an outward radial force of the stent graft body 105 to the downward force applied to the diaphragm 110. The downward force can be, for example, due to blood flow. In one embodiment, the diaphragm 110 is the lumen of the stent graft body 105 at or between the first end 116 of the visceral-vessel opening 115 and the second end 117 of the visceral-vessel opening 115. Can be located within.

The stent graft 100 also includes a visceral-vascular opening 115 defined on the side wall 118 of the stent graft body 105 between the first end 107 and the second end 109 of the stent graft body 105. In one embodiment, the visceral-vessel opening 115 can have a height in the range of about 10 mm to about 60 mm and a width in the range of about 5 mm to about 30 mm. In one embodiment, the visceral-vascular opening can be wider at the first end or proximal end than at the second end or tip, by between the visceral-vessel opening 115 and the two kidney openings 170. It can provide a large graft surface area to provide a stronger seal between the stent graft and the vascular structure. In another embodiment, the visceral-vessel opening 115 may be coated with a diversion material, such as a high drive density tied or woven self-expanding stent material. This diversion material allows patency to visceral vessels, for example, to minimize the degree of unstented aortic wall to assist in anchoring and sealing of the suprenal artery stent graft within the vascular structure. obtain. This may provide a stronger seal between the stent graft and the aorta. The diversion material may also allow the formation of thrombi and the development of arteries from them, and may support proper blood flow and blood pressure through this region of the stent graft body 105.

In addition, the stent graft 100 is defined by a visceral cavity 140 defined by a side wall 141 connected to one of the diaphragm 110 and the second opening 135, and to one of the side wall and visceral-vascular opening of the stent graft body. including. The visceral cavity 140 may provide blood flow to the SMA and celiac artery. In addition, the surgeon can utilize the visceral cavity 140 to place a bridging stent in the SMA and / or celiac artery.

In one embodiment, the stent graft 100 may further include a plurality of sealing rings attached to the stent graft body 105. In another embodiment, the plurality of sealing rings are proximal sealing rings connected to the stent graft body 105 at or directly adjacent to the first end 107 of the stent graft body 105. It may include 145. In a further embodiment, the proximal sealing ring 145 may have a two-stage structure defining the upper 146 and the lower 147. The lower 147 of the proximal sealing ring 145 can be aligned with the visceral-vascular opening 115 and aligned proximally, the lower 147 aligned distal to the upper 146 of the proximal sealing ring 145. Can be done. In one embodiment, the upper 146 of the proximal sealing ring 145 can be longitudinally separated from the lower 147 along the stent graft body 105 by a distance within the range of about 0 mm to about 40 mm. In a two-stage embodiment, the peripheral edge 104 of the first end 107 of the stent graft body 105 may have the same two-stage outer shape as the proximal seal ring 145. In one embodiment, the stent graft body 105 may have a length in the range of about 0 mm to about 20 mm, the lower part 147 of the proximal sealing ring 145 of the stent graft body 105 and the first visceral-vascular opening 115. Can extend between the ends of 1116.

The graft material of the stent graft body 105 may have the same boundaries as the proximal sealing ring 145 to avoid covering the lumbar arteries that deliver blood to the spinal column. In other embodiments, the graft material may have a uniform circumference along the upper boundary of the proximal sealing ring 145. In a further embodiment, the graft material may extend beyond the upper proximal boundary of the proximal sealing ring 145 to the top or proximal edge of the fixed stent 150.

In another embodiment, a plurality of sealing rings may include a visceral-vascular sealing ring 155 coupled to the stent graft body 105 such that the visceral-vascular sealing ring 155 surrounds the visceral-vessel opening 115. .. For example, the visceral-vascular sealing ring 155 may provide a tight liquid tightness around the SMA and celiac artery by applying a circumferential force that keeps the visceral-vessel opening 115 intact upon placement. The first end 161 of the at least one support sealing ring 160 is connected to the first side of the visceral-vascular sealing ring 155, and the second end 162 of the at least one support sealing ring 155 Multiple sealing rings may also include at least one supporting sealing ring 160 connected to the stent graft body 105 so that it is connected to the second side of the visceral-vascular sealing ring 155. The visceral-vascular sealing ring 155 also works in concert with the supporting sealing ring 160 to provide a radial radial force of the circumference to the stent graft body 105, eg, liquid tightness with the aorta (ie, blood seal). Can be provided. In a further embodiment, the at least one support sealing ring 160 may include a proximal support sealing ring 163, a distal support sealing ring 164, and a central support sealing ring 160. In one embodiment, the central support sealing ring 160 may be connected to the visceral-vascular sealing ring 155. Proximal support sealing ring 163 may be connected to the stent graft body 105 between the first end 107 of the stent graft body 105 and the central support sealing ring 160. The distal support sealing ring 164 can then be connected to the stent graft body 105 between the second end 109 of the stent graft body 105 and the central support sealing ring 160.

In yet another embodiment, the plurality of sealing rings are distal seals connected to the stent graft body 105 at or directly adjacent to the second end 109 of the stent graft body 105. It may include ring 165. In one embodiment, the two kidney openings 170 may be defined on the side wall 118 of the stent graft body 105 distal to the septum 110. In one embodiment, the distal sealing ring 165 may have two radial portions 166 joined by two arches 167. The two arches 167 may be arranged longitudinally along the side wall 118 of the stent graft body 105 and the two radial portions 166 may be arranged around the circumference of the stent graft body 105. The two arches 167 are aligned with the two kidney openings 170. In one embodiment, the effective diameter extending between the two radial portions 166 of the distal sealing ring 165 can be in the range of about 20 mm to about 50 mm. In one embodiment, the two bows 167 may have a width in the range of about 4 mm to about 30 mm. In embodiments where the kidney opening 170 is not provided within the side wall 118 of the stent graft body 105, the length of the stent graft body 105 can be shortened so that the kidney stent grafts can be ejected from the second end, thereby them. When a bridging stent is placed, it can have a gradual spread of curves or a large radius from the renal entrance and small holes in the target vessel. In yet another embodiment shown in FIGS. 7A-8B, the two kidney openings 170 on the side wall of the stent graft body can be the size and shape of the fenestration, allowing access to natural arteries. ..

In one embodiment applicable to the first, second and third aspects of the present disclosure, the bridging stent graft is disposed longitudinally along the length of the spiral bridging stent graft and on opposite sides. It may include a distant stent ring connected to the two wires. This sequence can beneficially prevent elongation of the bridging stent graft. Appropriate overlap with the stent graft extension 121, 126 connected to the third and fourth openings 120, 125, or the stent graft extension 131 connected to the first opening 130 is a stent graft debranching procedure. Can be sufficient to achieve passive fixation with bridging stent grafts. The length of this overlapping region can be shorter, for example if active fixation features are also used in stent grafts.

In a third aspect, the stent graft is
A stent graft body that defines a lumen with a first end and a second end,
A diaphragm that is connected to the stent graft body and defines at least three openings.
At least three stent graft extensions, each defining a lumen, with the first end of each of the at least three stent graft extensions connected to one of the at least three openings. Three stent graft extension parts and
A visceral-vascular opening defined on the side wall of the stent graft body between the first end and the second end of the stent graft body, wherein the diaphragm is disposed within the lumen of the stent graft body. And a visceral-vascular opening, wherein at least three openings in the diaphragm include a first opening, a second opening, a third opening and a fourth opening.
I will provide a.

Referring now to FIGS. 7A and 7B, in one embodiment, a stent graft comprising a stent graft body 105 defining a lumen having a first end 107 and a second end 109 corresponding to the proximal and distal ends, respectively. 100 is shown. The visceral-vessel opening 115 is defined on the side wall of the stent graft body 105 between the first end 107 and the second end 109 of the stent graft body 105. In addition, the diaphragm 110 is disposed within the lumen of the stent graft body 105 and is connected to the stent graft body 105. The diaphragm defines the first opening, the second opening, the third opening and the fourth opening. In one embodiment, each of the openings can receive, for example, a bridging stent, the subrenal segment can be connected to the first opening 130, and the abdominal cavity and SMA artery can be connected to the second opening 135. Renal arteries can be connected to the third and fourth openings 120, 125.

In one embodiment, the visceral cavity 140 may be defined by a diaphragm 110, a side wall of the stent graft body 105, and a visceral side wall 141 extending between the diaphragm 110 and the side wall of the stent graft body 105. In another embodiment, the fifth opening 137 is defined in the diaphragm between the visceral side wall and the side wall of the stent graft body 105. This fifth opening 137 actively stents or otherwise blocks the second opening, while beneficially allowing blood flow to the abdominal cavity and SMA arteries, and vice versa. There can also be. The fifth opening 137 can also bridge more than one of the abdominal cavity and SMA arteries with a stent graft.

The second and fifth openings 135, 137 are defined in the diaphragm 110 between the visceral side wall 141 and the side wall of the stent graft body 105. The visceral side wall 141 surrounds a portion of the visceral-vascular opening 115 defined between the second end 109 of the stent graft body 105 and the diaphragm 110.

In one embodiment, the second opening 135 and the fifth opening 137 may be arranged adjacent to each other. In another embodiment, the second opening 135 may be connected to the lumen-defining stent graft extension 136, and the fifth opening 137 may also be connected to the lumen-defining stent graft extension 138. .. In a further embodiment, each of the stent graft extension portions connected to one of the second and fifth openings can have a diameter in the range of about 6 mm to about 14 mm, of about 0.5 mm to about 40 mm. It can have a length within the range.

In a further embodiment, one or more of the first opening 120, the second opening 135, the third opening 120, the fourth opening 125 and the fifth opening 137 are reinforced. obtain.

In one embodiment, shown in FIG. 24 and applicable to all aspects of the present disclosure, the stent graft 300 comprises a plurality of anchors 385, each defining a small hole. The plurality of anchors 385 are arranged longitudinally spaced along the stent graft body 305. In a further embodiment, the stent graft 300 comprises a thread 386 having a first end 387 and a second end 388. The threads 386 can be slidably arranged through the small holes of the plurality of anchors 385 so that the stent graft body 305 has a partially expanded state and a fully expanded state. In the partially expanded state, the thread 386 can be under tension, the first end of the thread 387 can be fixedly connected to the first anchors 390 of the plurality of anchors 385, and the first of the threads 386. The second end 388 may be detachably connected to the second anchor 391 of the plurality of anchors. In the fully expanded state (see FIG. 24), the second end of the thread 388 can be released from the second anchor 391 and the thread 386 cannot be strained.

In one embodiment, the stent graft body 305 may expand at 50% to 95% of its fully expanded diameter in the partially expanded state. The partially dilated state in this way may allow the stent graft to be placed in the lumen and then repositioned. The smaller diameter of the partially dilated stent graft, for example, allows the stent graft to be moved and rotated proximal and distal to the desired position of the lumen for alignment with a suitable bifurcated vascular structure. Once in place, the removable end 388 of the thread 386 can be separated from the anchor 391 as described below, and the stent graft 300 transitions to a fully expanded state, for example by shape memory of the stent or balloon expansion. obtain.

In another embodiment, the plurality of anchors may be arranged on the side of the stent graft body facing the visceral-vascular opening. In a further embodiment, the plurality of anchors can be arranged as opposite lateral pairs (see FIG. 24). In a further embodiment, the plurality of anchors can be arranged in a zigzag pattern.

In one embodiment, the pores and threads 386 of the plurality of anchors 385 can be made of low friction material, transitioning the stent graft 300 from a partially expanded state to a fully expanded state.

The stent grafts of the present disclosure may contain any additional suitable components, including, but not limited to, radiopaque markers to aid visualization and facilitate accurate placement of the stent graft. These radiation opaque markers, for example in the shape of an "S" or in any other suitable form, of a gold band at the tip of each lumen of a given stent graft to indicate the orientation and orientation of the stent graft. It can take the form of a morphology or other directional marker. In one embodiment, the first or proximal ends 107, 207 of the stent graft body 105 may be coupled to the fixed stent 150. In addition, a bidirectional anchoring hook can be formed because a portion of the fixed stent 150 can be used to obtain reliable clues in the unaffected portion of the vessel wall. The fixation stent 150 may provide radial force fixation within the blood vessel in conjunction with a bidirectional hook. In another embodiment, the fixed stent 150 can be deflected away from the lumen of the stent graft body 105 to maintain fixation with the vascular structure even if the aneurysm progresses proximally.

In a fourth aspect, the present invention provides a method of arranging the stent graft 100 according to the first aspect of the present invention. The method involves (a) introducing a guidewire into an arterial configuration of any suitable size via arterial access, and (b) delivering a delivery catheter comprising a stent graft according to any of the aforementioned embodiments on the guidewire. Loading into, (c) moving the delivery catheter along the guide wire to introduce the delivery catheter into the arterial configuration of the appropriate size via arterial access, and (d) the Indwelling the stent graft into the lumen of the appropriately sized arterial structure and / or previously placed stent graft.

In one embodiment, the method may further comprise maintaining the stent graft in a partially compressed state via a toned thread, each arranged through a plurality of anchors defining a small hole. In one embodiment, thread tension can be reduced by opening one end of the wire from the first anchors of the plurality of anchors. Once the thread tension is reduced, the stent graft can then be expanded to a fully expanded state.

In one embodiment, the second aspect is (e) loading a second delivery catheter, including a bridging stent graft, onto a guidewire, (f) moving the second delivery catheter along the guidewire. Introducing a second delivery catheter into the lumen base 107 of the body of the stent graft 105 via arterial access, (g) a first kidney entrance 120 defined in the diaphragm 110, a second kidney entrance. Choose from 125, subrenal entrance 130 or visceral entrance 135, (h) lumens 121, 126, 131 or appropriately sized arterial lumens connected into and to the selected entrance. Introducing a second delivery catheter into any of the above, and (i) placing all or part of the bridging stent graft into the selected entrance or appropriately sized arterial lumen. Can include.

In a fifth aspect, the stent graft is
A stent graft body that defines a lumen with a first end and a second end,
A diaphragm connected to the stent graft body and defining a first opening, a second opening, and a third opening.
A first stent graft extension having a first end and a second end, wherein the first stent graft extension has a single lumen and the first stent graft extension. A first stent graft extension, with a first end connected to the diaphragm and arranged surrounding the first opening.
A second stent graft extension having a first end and a second end, wherein the second stent graft extension has a single lumen at the first end and the first. It has a bifurcation that defines the two lumens at the two ends, the first end of the second stent graft extension is connected to the diaphragm and is arranged surrounding the second opening. And the second stent graft extension,
A third stent graft extension having a first end and a second end, wherein the third stent graft extension has a single lumen at the first end and said third. A third stent graft extension, wherein the first end of the stent graft extension is connected to the diaphragm and is arranged to surround the third opening.
I will provide a.

Here, with reference to FIGS. 25A-26B, a stent 400 having a stent graft body 405 defining a lumen having a first end 406 and a second end 407 is shown. Connected to the stent graft body 405 is a diaphragm 410 defining the first opening 415, the second opening 420 and the third opening 425. The first stent graft extension 430 defines a single lumen, has a first end 431 and a second end 432, and the first end 431 of the first stent graft extension 430 , Connected to the diaphragm 410 and arranged around the first opening 415. The second stent graft extension 435 has a single lumen at the first end 436 and a bifurcation point 437 at the second end 438 defining the two lumens. The first end 436 of the second stent graft extension 435 is connected to the septum 410 and is arranged surrounding the second opening 420. And the third stent graft extension 440 has a first end 441 and a second end 442. The third stent graft extension 440 has a single lumen at the first end 441 and the first end 441 of the third stent graft extension 440 is connected to the diaphragm 410 and the third Arranged around the opening 425.

In one embodiment shown in FIGS. 26A-26B, the first opening 415 may be circular, the second opening 420 may be elliptical, and the third opening 425 may be circular. possible. In this embodiment, the stent graft 400 may further include a fourth opening 445 defined at the diaphragm 410 and circular. And the fourth stent graft extension 450 has a first end 451 and a second end 452, and the fourth stent graft extension 450 has a single lumen at the first end 451. The first end 451 of the fourth stent graft extension 450 is connected to the diaphragm 410 and is arranged surrounding the fourth opening 445. In one embodiment, the third opening 425 and the fourth opening 445 may be arranged adjacent to each other. In an alternative embodiment (not shown), the first opening can be circular, the second opening can be circular, and the third opening can be oval. In a further embodiment, the fourth opening can be defined in the diaphragm and is located adjacent to the circular second opening.

In another embodiment, the first opening 415 is circular, the second opening 420 is elliptical, and the third opening 425 is elliptical. The third stent graft extension 440 may have a bifurcation point 443 that defines the two lumens at the second end 442. In one embodiment, the second opening 420 is arranged between the first opening 415 and the third opening 425. In a further embodiment, the major axis of the second opening 420 may be aligned perpendicular to the major axis of the third opening 425. In yet another embodiment, the minor axis of the second opening 420 is aligned with the major axis of the third opening 425.

In one embodiment, the two lumens of the second stent graft extension 435 each have a diameter in the range of about 4 mm to about 12 mm. In another embodiment, the major axis of the second opening 420 may have a length in the range of about 4 mm to about 36 mm, and the minor axis of the second opening 420 may be about 4 mm to about 24 mm. Can have a length within the range

In another embodiment, the two lumens of the third stent graft extension 440 may each have a diameter in the range of about 6 mm to about 14 mm. In a further embodiment, the major axis of the third opening has a length in the range of about 6 mm to about 42 mm, and the minor axis of the third opening has a length in the range of about 6 mm to about 28 mm. Has

In a further embodiment, the bifurcation point 437 of the second stent graft extension 435 can occur at a position within the range of about 0 mm to about 50 mm from the diaphragm 410, and the bifurcation point 443 of the third stent graft extension 440 , It occurs at a position within a range of about 0 mm to about 50 mm from the diaphragm 410. In some embodiments, the recess at the bifurcation away from the septum provides a recess that allows the selection of one of the two lumens of the second and third graft extensions via a bendable catheter tip. Can be generated. This can help reduce the time it takes to get the bridging stent in place, thereby reducing the amount of fluorescence and radiation used to visualize the placement of the device during surgery. In another embodiment, the first stent graft extension 430, the second stent graft extension 435, and the third stent graft extension 440 each have a length in the range of about 5 mm to about 50 mm. obtain.

In one embodiment, the first end 438 of the second stent graft extension 435 is tapered and the first end 441 of the third stent graft extension 440 is tapered. .. In a further embodiment, the first end 431 of the first stent graft extension 430 is tapered.

In the sixth aspect, the stent graft is
A stent graft body that defines a lumen with a first end and a second end,
A diaphragm that is connected to the stent graft body within the lumen and defines at least three openings.
At least three stent graft extensions, each defining a lumen, with the first end of each of the at least three stent graft extensions connected to one of the at least three openings. Three stent graft extension parts and
Visceral-vascular openings defined on the sidewalls of the stent graft body,
Two kidney openings defined on the side wall of the stent graft body distal to the septum,
A permeable membrane material covering at least one of the visceral-vascular opening and the two kidney openings.
I will provide a.

Here, with reference to FIGS. 27A-27B, a stent graft 500 with a stent graft body 505 defining a lumen having a first end 506 and a second end 507 is shown. The septum 510 is connected to the stent graft body 505 within the lumen, and the septum 510 defines at least three openings. In the illustrated embodiment, the diaphragm 510 has four openings: a first opening 530, a second opening 535, a third opening 520 and a fourth opening 525. Stent Graft 500 also includes stent graft extension 521, 526, 513, 536, each having a first end connected to one of openings 520, 525, 530, 535, respectively. , Each defines a lumen. The visceral-vessel opening 515 is defined on the side wall 518 of the stent graft body 505. The two kidney openings 570 are also defined at the side wall 515 of the stent graft body 505, which is distal to the septum 510. The permeable membrane material 571 covers at least one of a visceral-vascular opening 518 and two kidney openings 570.

In one embodiment, the permeable membrane material 571 may be perforable. For example, catheters, guide wires, bridging stent grafts or other instruments can be used to perforate the permeable membrane material 571. During surgery, the bridging stent graft can be placed by perforation in the permeable membrane material 571 so that there is a seal between the bridging stent graft and the permeable membrane material 571. In a further embodiment, the permeable membrane material 571 can be configured to be sealed via a thrombus in vivo. In another embodiment, the permeable membrane material 571 may include, but are not limited to, one or more of nitinol, polytetrafluoroethylene (“PTFE”), polyester, non-absorbable polymers and combinations thereof. .. Further, the permeable membrane material 571 can be, for example, a woven fabric, a mesh, or an electrospan.

In another embodiment, the second end 507 of the stent graft body 505 is distal with respect to blood flow so that blood flow enters through the first end 506 and exits through the second end 507. Can be arranged in. The diameter of the stent graft body 505 at the second end 507 can be larger than the diameter of the stent graft body 505 at the first end 506. This sequence may assist in colonizing the stent graft 500 against the aortic wall and resisting migration by blood flow. In a further embodiment, the second end 507 of the stent graft body 505 is bell-shaped as shown in FIG. 27A in the expanded exvivo state.

In one embodiment, the stent graft may include one or more sealing rings 555 connected to a stent graft body 505 that surrounds one or more of two kidney openings 570 and visceral-vascular openings 518.

In one embodiment, the two kidney openings 570 can be a fenestration. In another embodiment, the two kidney openings 570 can be two arches as previously described in connection with the second aspect of the invention.

Various embodiments of the stent graft according to the first, second, third, fifth, and sixth aspects of the present invention are described in FIGS. 17 to 23 and 25A to 27B according to the fourth aspect of the present invention. Shown in one of the major visceral parts or the thoracic aorta after in vivo placement by the method.

Although specific embodiments have been exemplified and described herein, it will be appreciated by those skilled in the art that any sequence estimated to achieve the same purpose can be substituted for the specific embodiments shown. .. The present application shall include any modification or modification of embodiments of the present invention. It should be understood that the above description is exemplary and not limiting, and that the expressions or terminology used herein are not limiting for illustration purposes. Unless otherwise noted, the above embodiments and other embodiments may be combined, as will be apparent to those skilled in the art in testing the above description.

Claims (17)

It is a stent graft
A stent graft body defining a lumen having a first end and a second end , wherein the first end of the stent graft body is configured to be a proximal end and a second end of the stent graft body. The part is configured to be the tip, with the stent graft body ,
A first stent graft extension having a first end and a second end, wherein the first stent graft extension has a single lumen and is the first of the first stent graft extension. A first stent graft extension, one end of which is connected to a second end of the stent graft body ,
A second stent graft extension having a first end and a second end, wherein the second stent graft extension has a single lumen at the first end and said the first. It has a branch point defines two lumens at second end, the first end of the second stent graft extending portion is connected to the second end of the stent graft main body, a second stent graft With the extension part
A third stent graft extension having a first end and a second end, wherein the third stent graft extension has a single lumen at the first end and said third. the first end of the stent graft extending portion is connected to the second end of the stent graft main body, and a third stent graft extending portion,
The first stent graft extension portion, the second stent graft extension portion, and the third stent graft extension portion are arranged entirely outward with respect to the lumen of the stent graft body, and are simply arranged with the stent graft body. A diaphragm connected to the stent graft body at the second end of the lumen so that it forms a unit structure, the diaphragm being the first opening, the second opening, and the third. The opening of the first stent graft is defined, and the first end of the first stent graft extension is connected to the diaphragm and is arranged so as to surround the first opening of the second stent graft extension. The first end is connected to the diaphragm and is arranged surrounding the second opening, and the first end of the third stent graft extension is connected to the diaphragm and the third. The first opening is circular, the second opening is elliptical, and the minor axis of the second opening is the extension of the second stent graft. With a diaphragm, which is larger than the diameter of each of the two lumens of the meatus,
Including stent graft. Before Symbol third opening is circular, the stent graft of claim 1. A fourth opening defined in the diaphragm, wherein the fourth opening is circular, and a fourth opening.
A fourth stent graft extension having a first end and a second end, wherein the fourth stent graft extension has a single lumen at the first end and said the first. A fourth stent graft extension, wherein the first end of the fourth stent graft extension is connected to the diaphragm and is arranged around the fourth opening.
The stent graft according to any one of claims 1 and 2, further comprising. The stent graft according to claim 3, wherein the third opening and the fourth opening are arranged adjacent to each other. The third opening front SL is elliptical, stent graft of claim 1. The stent graft according to any one of claims 1 and 5, wherein the extending portion of the third stent graft has a branch point defining two lumens at the second end. The second opening is arranged between the first opening and the third opening, and the long axis of the second opening is perpendicular to the long axis of the third opening. The stent graft according to any one of claims 1 and 5 to 6, which is arranged. The stent graft according to any one of claims 1 and 5 to 7, wherein the minor axis of the second opening is aligned with the major axis of the third opening. The two lumens of the second stent graft extending portion has respectively a diameter of about 4mm up to about 12 mm, the stent graft according to any one of claims 1-8. The long axis of the second opening has a length ranging from about 4mm to about 36 mm, the minor axis of the second opening has a length of about 4mm up to about 24 mm, according to claim 1 9. The stent graft according to any one of 9. The two lumens of the third stent graft extension portion, each having a diameter of about 6mm up to about 14 mm, the stent graft according to any one of claims 6-10. Longitudinal axis of the third opening portion has a length ranging from about 6mm to about 42mm, the short axis of the third opening, having a length of about 6mm up to about 28mm, claim 6 The stent graft according to any one of 1 to 11. Branch point of the second stent graft extending portion is generated at a position ranging from about 10mm to about 0mm from the diaphragm, a branch point of the third stent graft extending portion is from about 0mm to about 10mm from the diaphragm The stent graft according to claim 1, which occurs at an extended position. Any one of claims 1 to 13, wherein the first end of the second stent graft extension is tapered and the first end of the third stent graft extension is tapered. The stent graft according to item 1. The stent graft according to any one of claims 1 to 14, wherein the first end of the extending portion of the first stent graft is tapered. Said first stent graft extending portion, said second stent graft extending portion, and the third stent graft extending portion has a length of about 5mm up to about 50mm, respectively, any of claims 1 to 15 The stent graft according to item 1. Claims 1 to 16 , wherein the diaphragm, the first stent graft extension, the second stent graft extension, and the third stent graft extension form a single unit structure with the stent graft body. The stent graft according to any one of the above.

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